Stryker Spine Division RA and QA Consultant with Oxford International @ (January 2011 - January 2011)
Manager of US Product Safety and Compliance @ (January 2009 - January 2010)
Quality Manager Complaints @ (January 2014 - January 2015)
Manager Quality Systems, Audit and CAPA @ (January 2013 - January 2014)
Post Market Surveillance and CAPA Manager @ (January 2011 - January 2013)
Complaints Manager @ (January 2008 - January 2009)
Quality Assurance Manager @ (January 2008 - January 2008)
Quality Manager for Kerr Plant @ (January 2005 - January 2007)
Quality Systems Supervisor and Engineer @ (January 1997 - January 2005)
Gail Warner Education
Rensselaer Polytechnic Institute
Rensselaer Polytechnic Institute
BSME (Mechanical Engineering)
Gail Warner Skills
Quality Assurance
CAPA
FDA
Six Sigma
ISO 13485
Lean Manufacturing
V&V
Quality Control
Software Documentation
Manufacturing
Kaizen
Training
Complaint Management
Leadership
Management
Project Management
Product Development
Auditing
Regulatory Requirements
Testing
21 CFR Part 11
Inspection
Quality Auditing
Cross-functional Team Leadership
Root Cause Analysis
Computer System Validation
Continuous Improvement
Design of Experiments
Regulatory Affairs
Design Control
Quality Management
GMP
Quality System
ISO 14971
Sop
Internal Audit
Document Management
Process Improvement
Iso 9000
Medical Devices
DMAIC
FDA GMP
R&D
Corrective and Preventive Action (CAPA)
Verification and Validation (V&V)
U.S. Food and Drug Administration (FDA)
Gail Warner Summary
Gail Warner, based in Irvine, CA, US, is currently a Director, Quality at Edwards Lifesciences. Gail Warner brings experience from previous roles at Edwards Lifesciences, Masimo and Stryker. Gail Warner holds a Rensselaer Polytechnic Institute. With a robust skill set that includes Quality Assurance, CAPA, FDA, Six Sigma, ISO 13485 and more. Gail Warner has 2 emails and 3 mobile phone numbers on RocketReach.
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